To determine the kidney function in patients before and after enhanced external counterpulsation treatment
| ISRCTN | ISRCTN11560035 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11560035 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/10/2009
- Registration date
- 17/11/2009
- Last edited
- 23/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Prajej Ruangkanchanasetr
Scientific
Scientific
Assistant Professor, Division of Nephrology
Department of Medicine
Phramongkutklao Hospital (Royal Thai Army Hospital)
315 Rajavithi Road
Rajathevi
Bangkok
10240
Thailand
| Phone | +66 (0)2 644 4676 |
|---|---|
| prajej@gmail.com |
Study information
| Study design | Single-centre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | To determine the kidney function by using serum cystatin C in patients before and after enhanced external counterpulsation treatment |
| Study objectives | Enhanced external counterpulsation (EECP) is based on the principle of diastolic augmentation to increase coronary flow while simultaneously decreasing systolic afterload. We proposed that EECP treatment could improve cardiac function, therefore might improve kidney function. The aim of the trial is to see whether EECP treatment can slow the progression of kidney disease in patients with ischemic heart disease and congestive heart failure. |
| Ethics approval(s) | Institutional Review Board of Piyavate Hospital, approved on 25/10/2006 (ref: 006/2006) |
| Health condition(s) or problem(s) studied | Ischaemic heart disease, chronic stable angina, chronic stable heart failure |
| Intervention | All patients will receive EECP typically involving 35 x 1-h sessions of counterpulsations over a 7-week period. |
| Intervention type | Other |
| Primary outcome measure | Serum cystatin C All primary and secondary outcome measures will be assessed before and within 1 month, and 5-7 months after completion of EECP treatment of 35 sessions. |
| Secondary outcome measures | 1. Calculated glomerular filtration rate (GFR) 2. Serum N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) 3. Ejection fraction determined by echocardiography All primary and secondary outcome measures will be assessed before and within 1 month, and 5-7 months after completion of EECP treatment of 35 sessions. |
| Overall study start date | 01/11/2006 |
| Completion date | 30/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 26 |
| Key inclusion criteria | 1. Both males and females, age >18 years 2. Patients with refractory angina, chronic stable angina or chronic stable heart failure 3. Willing to participate in the study with informed consent |
| Key exclusion criteria | 1. Patient with the diagnosis of congestive heart failure within 1 month prior to study entry 2. Patient with the diagnosis of acute coronary syndrome within 1 month prior to study entry 3. Patient with uncontrolled blood pressure (>180/110 mmHg) 4. Patient with cardiac arrhythmia (e.g. atrial fibrillation or atrial flutter or frequent premature ventricular contractions) that may interfere with triggering of EECP system 5. Patients with severe lower extremity vaso-occlusive disease 6. Patients with end stage renal disease requiring renal replacement therapy |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 30/11/2009 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Assistant Professor, Division of Nephrology
Bangkok
10240
Thailand
10240
Thailand
Sponsor information
Piyavate Hospital (Thailand)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Prajej Ruangkanchanasetr
998 Rimklongsamsen Rd (Rama 9 Rd)
Bangkapi, Huaykwang
Bangkok
10310
Thailand
| Phone | +66 (0)81 311 7815 |
|---|---|
| prajej@gmail.com | |
| Website | http://www.piyavate.com/ |
Funders
Funder type
Hospital/treatment centre
This is an investigator-initiated study, carried out in collaboration with the following hospitals:
No information available
Piyavate Hospital (Thailand)
No information available
Ramathibodi Hospital (Thailand)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/09/2013 | Yes | No |
