Status:
COMPLETED
Measurement of Endothelial Function and Cardiac Output: New Methods
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Bayer
Health Twist GmbH
Conditions:
Heart Failure
Hypertension, Pulmonary
Eligibility:
All Genders
35-80 years
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 preser...
Eligibility Criteria
Inclusion
- 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)
- EF \<=45%, Simpson Biplan PH
- NICE-Classification 2013 I/II
- PAH \>= 25 mmHg
- Precapillary PAH: Wedge-pressure \<= 15 mmHg, CO normal or low
- Postcapillary PAH: Wedge-pressure \>= 15 mmHg, CO normal or low
- Diabetic nephropathy:
- Diabetes mellitus Type 2 with oral or Insulin therapy and one or more of the following:
- Diabetic nephropathy has been diagnosed before (anamnesis)
- 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)
- 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
- AH:
- Hypertension diagnosed at least 6 months except structural heart disease: EF \> 55% and no sign of HFpEF
- No symptoms of coronary heart disease
- Possibility to take part in cardiac stress test
- Stable pharmacologic therapy of Hypertension for at least 4 weeks
- Systolic blood pressure \<140 mmHG during Screening
Exclusion
- 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
- Uncontrolled Hyper/Hypotension (\>180mmHg, \<95mmHg)
- Patient taking part in Rehabilitation program
- Diagnosed Malignant disease or disease with life expectancy \< 1 year
- Anemia with Hb\<10mg/dl
- Untreated significant thyroid disease
- HFpEF, Hypertension and PH:
- Patient incapable of cardiac stress test (e.g. because of orthopedic Problems)
- Significant changes in cardiovascular Status over the two weeks of study
- Instable cardiopulmonary Status over the last four weeks
- HFrEF:
- I.v. Treatment with inotropic drug or diuretic in the last 7 days before Screening
- Myocardial infarction in the last 4 weeks
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT02299960
Start Date
August 1 2014
End Date
October 1 2015
Last Update
June 10 2016
Active Locations (1)
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1
Charite Universitaetsmedizin
Berlin, State of Berlin, Germany, 10117