Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-08 @ 6:27 AM
Study NCT ID:
NCT02299960
Status:
COMPLETED
Last Update Posted:
2016-06-10
First Post:
2014-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Endothelial Function and Cardiac Output: New Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples, 51,4ml per Patient'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-09', 'studyFirstSubmitDate': '2014-11-20', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test-retest-reliability EndoPAT', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Test-retest-reliability circulating endothelial cells', 'timeFrame': '2 weeks'}, {'measure': 'Test-retest-reliability NICOM', 'timeFrame': '2 weeks'}, {'measure': 'Correlation: Cardiac Output on exertion and cardiopulmonary exercise test and 6 Minute Walking test', 'timeFrame': '2 weeks'}, {'measure': 'Correlation: circulating endothelial cells and EndoPAT and endothelial function', 'timeFrame': '2 weeks', 'description': 'will include the molecular diagnostic of circulating endothelial cells'}, {'measure': 'Variability of biomarkers of myocardiac remodelling and of cardiorenal syndrome', 'timeFrame': '2 weeks'}, {'measure': 'Correlation cardiac Output on exertion and echocardiography in HFpEF', 'timeFrame': '2 weeks'}, {'measure': 'Clinical feasibility of circulating endothelial cells and EndoPAT', 'timeFrame': '2 weeks'}]}, 'conditionsModule': {'keywords': ['EndoPAT', 'NICOM', 'circulating endothelial cells'], 'conditions': ['Heart Failure', 'Hypertension, Pulmonary', 'Hypertension', 'Diabetic Nephropathies']}, 'referencesModule': {'references': [{'pmid': '28555533', 'type': 'DERIVED', 'citation': 'Weisrock F, Fritschka M, Beckmann S, Litmeier S, Wagner J, Tahirovic E, Radenovic S, Zelenak C, Hashemi D, Busjahn A, Krahn T, Pieske B, Dinh W, Dungen HD. Reliability of peripheral arterial tonometry in patients with heart failure, diabetic nephropathy and arterial hypertension. Vasc Med. 2017 Aug;22(4):292-300. doi: 10.1177/1358863X17706752. Epub 2017 May 30.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to analyse test-retest-reliability of functional quantification of endothelial dysfunction through puls-amplitude-tonometry in patients with heart failure with preserved/reduced ejection fraction, pulmonary hypertension, arterial hypertension and diabetic nephropathy. In the same group, test-retest-reliability of circulating endothelial cells as well as test-retest reliability of non invasive cardiac output Monitoring will be observed and analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from the conditions stated above', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinically stable for the last 4 weeks (not for HFrEF: 7 days)\n* Signed consent form\n\nHFpEF:\n\n* Baseline-Echocardiography:\n* hospitalization \\<= 12 months with diagnosis heart failure and E/E' \\> 8 or E' \\< 8 cm/s or\n* BNP \\>= 100pg/ml or NT-proBNP \\>= 300pg/ml in the last 6 months or\n* LAVI \\> 28 ml/m² and E/E' \\> 8 or E' \\< 8cm/s or PAPsys \\> 40mmHg and E/E' \\> 8 or E' \\< 8 cm/s\n* Possibility to take part in cardiac stress test\n* Heart failure NYHA I-III\n* Sinus rhythm\n* Max. O2-uptake on exertion \\< 20ml/kgBW/min\n\nHFrEF\n\n* HFrEF due to ischemic or non-ischemic reasons\n* NYHA I-III\n* Individually optimized and stable pharmacological therapy (including beta-blocker, ACE-Inhibitor, AT1-antagonist, aldosterone-antagonist)\n* EF \\<=45%, Simpson Biplan PH\n* NICE-Classification 2013 I/II\n* PAH \\>= 25 mmHg\n* Precapillary PAH: Wedge-pressure \\<= 15 mmHg, CO normal or low\n* Postcapillary PAH: Wedge-pressure \\>= 15 mmHg, CO normal or low\n\nDiabetic nephropathy:\n\n* Diabetes mellitus Type 2 with oral or Insulin therapy and one or more of the following:\n* Diabetic nephropathy has been diagnosed before (anamnesis)\n* Macroalbuminuria: Urine Albumine/Creatinine-ratio \\> 300mg/g Creatinine (\\>34mg/mmol) in 2 out of 3 tests of Urine in the morning and GFR \\<90ml/min/1.73m² (CKD-EPI)\n* Microalbuminuria: 30-300mg/g Creatinine (\\>=3.4 mg/mmol but \\<34mg/mmol) tested as above and GFR \\< 90 ml/min/1.73m² and diabetic retinopathy\n\nAH:\n\n* Hypertension diagnosed at least 6 months except structural heart disease: EF \\> 55% and no sign of HFpEF\n* No symptoms of coronary heart disease\n* Possibility to take part in cardiac stress test\n* Stable pharmacologic therapy of Hypertension for at least 4 weeks\n* Systolic blood pressure \\<140 mmHG during Screening\n\nExclusion Criteria:\n\n* Patient incapable of contracting\n* Angina pectoris \\> CCS II\n* Coronary Intervention in the last 4 weeks or scheduled Intervention/Bypass\n* Myocardial infarction in the last 3 months\n* Stroke in the last 3 months\n* Valvular heart disease \\> II°\n* Cardiomyopathy due to Infiltrate/hypertrophic obstruction (e.g. HOCM, Amyloidosis)\n* Congenital complex heart disease\n* Active myocarditis\n* Significant lung disease\n* Significant Cardiac dysrhythmia\n* Scheduled changes in medication during time of study\n* (Scheduled) heart transplant\n* Cardiac resynchronisation therapy over the last three months\n* ICD/Pacemaker-implant in the last 4 weeks\n* Uncontrolled Hyper/Hypotension (\\>180mmHg, \\<95mmHg)\n* Patient taking part in Rehabilitation program\n* Diagnosed Malignant disease or disease with life expectancy \\< 1 year\n* Anemia with Hb\\<10mg/dl\n* Untreated significant thyroid disease\n\nHFpEF, Hypertension and PH:\n\n* Patient incapable of cardiac stress test (e.g. because of orthopedic Problems)\n* Significant changes in cardiovascular Status over the two weeks of study\n* Instable cardiopulmonary Status over the last four weeks\n\nHFrEF:\n\n* I.v. Treatment with inotropic drug or diuretic in the last 7 days before Screening\n* Myocardial infarction in the last 4 weeks"}, 'identificationModule': {'nctId': 'NCT02299960', 'briefTitle': 'Measurement of Endothelial Function and Cardiac Output: New Methods', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Pilot Study: Analysis of Endothelial Function Through Circulating Endothelial Cells and Puls-amplitude-tonometry and of Non-invasive Measurement of Cardiac Output on Exertion in Patients With Heart Failure, Pulmonary Hypertension, Arterial Hypertension and Diabetic Nephropathy', 'orgStudyIdInfo': {'id': 'ENDO-CEC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HFpEF', 'description': 'patients with heart failure with preserved ejection fraction', 'interventionNames': ['Device: Endo-PAT', 'Device: NICOM']}, {'label': 'HFrEF', 'description': 'patients with heart failure with reduced ejection fraction', 'interventionNames': ['Device: Endo-PAT']}, {'label': 'AH', 'description': 'patients with hypertension', 'interventionNames': ['Device: Endo-PAT', 'Device: NICOM']}, {'label': 'Nephropathy', 'description': 'patients with diabetic nephropathy', 'interventionNames': ['Device: Endo-PAT']}], 'interventions': [{'name': 'Endo-PAT', 'type': 'DEVICE', 'description': 'Analysis of endothelial function through pulse-amplitude-tonometry', 'armGroupLabels': ['AH', 'HFpEF', 'HFrEF', 'Nephropathy']}, {'name': 'NICOM', 'type': 'DEVICE', 'description': 'Non-invasive measurement of cardiac output', 'armGroupLabels': ['AH', 'HFpEF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charite Universitaetsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Hans-Dirk Duengen, PD Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Charite Universitaetsmedizin Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}, {'name': 'Health Twist GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral candidate', 'investigatorFullName': 'Sebastian Beckmann', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}