Contact information
Type
Scientific
Primary contact
Dr Frank Edelmann
ORCID ID
Contact details
Robert- Koch- Str. 40
Gottingen
37073
Germany
+49 (0)551 392658
fedelmann@med.uni-goettingen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Ex-DHF-P
Study hypothesis
Supervised combined endurance and strength exercise training for three months, two to three times/week improves the exercise capacity and quality of life in patients with diastolic heart failure compared to patients in a non-training control group.
Please note that as of 01/11/2007 this trial has now been completed. The previous anticipated end date of this trial was 30/09/2008.
Ethics approval
Ethics approval received from the ethics committees of the Universities of Gottingen, Berlin, Munich (Germany) on the 14th September 2006 (ref: 38/9/06), following by amendment 1 on 22nd January 2007 and amendment 2 on 7th March 2007.
Study design
Multicentre, prospective, randomised, controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Diastolic Heart Failure
Intervention
Once randomised, patients will either participate in an combined endurance and strength exercise training two to three times/week for three months or perform their usual activities. After three months and the second visit all patients participate in the training for another three months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Change in peak maximal oxygen uptake (VO2), measured at three months.
Secondary outcome measures
1. Change in quality of life
2. Change in early left ventricular filling-to-peak early diastolic myocardial velocity ratio (E/E' ratio)
3. Change in six-minute walking distance
4. Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) and other parameters of neurohumoral activation
5. Change in Heart Rate Variability (HRV) and Heart Rate Turbulence (HRT)
6. Change in blood levels of parameters of collagen turnover, metabolic syndrome and inflammation
7. Change in parameters of diastolic dysfunction:
7.1. Early-to-Atrial left ventricular filling ratio (E/A ratio)
7.2. Early left ventricular filling Deceleration Time (EDT)
7.3. Isovolumic Relaxation Time (IVRT)
7.4. Systolic-to-Diastolic pulmonary venous flow ratio (S/D ratio)
7.5. Pulmonary Venous peak Atrial contraction Reversed velocity (PVAR)
7.6. Colour M-Mode flow propagation Velocity (Vp)
7.7. Doppler echocardiography-derived index of myocardial performance (TEI-Index)
7.8. Left Ventricular mass (LV-mass)
7.9. Left Ventricular volume (LV-volume)
7.10. Left Atrial volume (LA-volume)
8. Severity of diastolic dysfunction (echocardiography)
9. Change in endothelial function, safety, compliance, cardiovascular morbidity and mortality
Secondary outcomes are measured at three and six months.
Overall trial start date
01/10/2006
Overall trial end date
01/11/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. At least one of the following risk factors for the development of a diastolic dysfunction:
1.1. Diabetes
1.2. Hypertension
1.3. Smoking
1.4. Hyperlipidaemia
1.5. Overweight
2. Aged greater than or equal to 45 years
3. Written informed consent
4. New York Heart Association (NYHA) II or III
5. Diastolic dysfunction greater than or equal to grade one (echocardiographically determined)
6. Left Ventricular Ejection Fraction (LVEF) greater than or equal to 50%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 (40 versus 20)
Participant exclusion criteria
1. Diseases limiting the validity of consent (psychiatric diseases, dementia etc.,)
2. Change in medication within the last two weeks
3. Limited exercise capacity due to musculo-skeletal diseases or pulmonary disease
4. Myocardial Infarction (MI) or bypass surgery in the patient's history or clinically significant Coronary Artery Disease (CAD) (angina or known untreated stenosis of more than 50%) or peripheral arterial obstructive disease greater than or equal to IIa
5. Pregnant or nursing women and women before menopause without sufficient contraception
6. Participaton in another study currently or within the last 30 days
Recruitment start date
01/10/2006
Recruitment end date
01/11/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Robert- Koch- Str. 40
Gottingen
37073
Germany
Sponsor information
Organisation
Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)
Sponsor details
c/o Professor Dr Burkert Pieske
Robert- Koch- Str. 40
Gottingen
37073
Germany
pieske@med.uni-goettingen.de
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) - Health Research, Competence Network on Heart Failure
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary