Measurement of Endothelial Function and Cardiac Output: New Methods

NCT02299960 | Completed

• 1 other identifier: ENDO-CEC
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Hypertension, Pulmonary; Hypertension; Diabetic Nephropathies

Keywords

EndoPAT; NICOM; circulating endothelial cells

Outcome Measures

Primary Outcomes (1)

• Test-retest-reliability EndoPAT

  2 weeks

Secondary Outcomes (7)

• Test-retest-reliability circulating endothelial cells

  2 weeks

• Test-retest-reliability NICOM

  2 weeks

• Correlation: Cardiac Output on exertion and cardiopulmonary exercise test and 6 Minute Walking test

  2 weeks

• Correlation: circulating endothelial cells and EndoPAT and endothelial function

  2 weeks

• Variability of biomarkers of myocardiac remodelling and of cardiorenal syndrome

  2 weeks

Study Arms (4)

HFpEF

patients with heart failure with preserved ejection fraction

Device: Endo-PAT; Device: NICOM

HFrEF

patients with heart failure with reduced ejection fraction

Device: Endo-PAT

AH

patients with hypertension

Device: Endo-PAT; Device: NICOM

Nephropathy

patients with diabetic nephropathy

Device: Endo-PAT

Interventions

Endo-PAT DEVICE

Analysis of endothelial function through pulse-amplitude-tonometry

AH; HFpEF; HFrEF; Nephropathy

NICOM DEVICE

Non-invasive measurement of cardiac output

AH; HFpEF

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from the conditions stated above

You may qualify if:

• Clinically stable for the last 4 weeks (not for HFrEF: 7 days)
• Signed consent form
• HFpEF:
• Baseline-Echocardiography:
• hospitalization \<= 12 months with diagnosis heart failure and E/E' \> 8 or E' \< 8 cm/s or
• BNP \>= 100pg/ml or NT-proBNP \>= 300pg/ml in the last 6 months or
• LAVI \> 28 ml/m² and E/E' \> 8 or E' \< 8cm/s or PAPsys \> 40mmHg and E/E' \> 8 or E' \< 8 cm/s
• Possibility to take part in cardiac stress test
• Heart failure NYHA I-III
• Sinus rhythm
• Max. O2-uptake on exertion \< 20ml/kgBW/min
• HFrEF
• HFrEF due to ischemic or non-ischemic reasons
• NYHA I-III
• Individually optimized and stable pharmacological therapy (including beta-blocker, ACE-Inhibitor, AT1-antagonist, aldosterone-antagonist)

You may not qualify if:

• Patient incapable of contracting
• Angina pectoris \> CCS II
• Coronary Intervention in the last 4 weeks or scheduled Intervention/Bypass
• Myocardial infarction in the last 3 months
• Stroke in the last 3 months
• Valvular heart disease \> II°
• Cardiomyopathy due to Infiltrate/hypertrophic obstruction (e.g. HOCM, Amyloidosis)
• Congenital complex heart disease
• Active myocarditis
• Significant lung disease
• Significant Cardiac dysrhythmia
• Scheduled changes in medication during time of study
• (Scheduled) heart transplant
• Cardiac resynchronisation therapy over the last three months
• ICD/Pacemaker-implant in the last 4 weeks

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Bayer: collaborator
• Health Twist GmbH: collaborator

Study Sites (1)

Charite Universitaetsmedizin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

• 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.

  PMID: 28555533 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, 51,4ml per Patient

MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary; Hypertension; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Hans-Dirk Duengen, PD Dr. med.

  Charite Universitaetsmedizin Berlin

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral candidate

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

DE (1)