Condition category
Circulatory System
Date applied
25/10/2009
Date assigned
17/11/2009
Last edited
23/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Prajej Ruangkanchanasetr

ORCID ID

Contact details

Assistant Professor
Division of Nephrology
Department of Medicine
Phramongkutklao Hospital (Royal Thai Army Hospital)
315 Rajavithi Road
Rajathevi
Bangkok
10240
Thailand
+66 (0)2 644 4676
prajej@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

To determine the kidney function by using serum cystatin C in patients before and after enhanced external counterpulsation treatment

Acronym

Study hypothesis

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

Institutional Review Board of Piyavate Hospital, approved on 25/10/2006 (ref: 006/2006)

Study design

Single-centre observational study

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2006

Overall trial end date

30/11/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

26

Participant 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

Recruitment start date

01/11/2006

Recruitment end date

30/11/2009

Locations

Countries of recruitment

Thailand

Trial participating centre

Assistant Professor, Division of Nephrology
Bangkok
10240
Thailand

Sponsor information

Organisation

Piyavate Hospital (Thailand)

Sponsor details

c/o Dr Prajej Ruangkanchanasetr
998 Rimklongsamsen Rd (Rama 9 Rd)
Bangkapi
Huaykwang
Bangkok
10310
Thailand
+66 (0)81 311 7815
prajej@gmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.piyavate.com/

Funders

Funder type

Hospital/treatment centre

Funder name

This is an investigator-initiated study, carried out in collaboration with the following hospitals:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Piyavate Hospital (Thailand)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ramathibodi Hospital (Thailand)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24021027

Publication citations

  1. Results

    Ruangkanchanasetr P, Mahanonda N, Raungratanaamporn O, Ruckpanich P, Kitiyakara C, Chaiprasert A, Adirekkiat S, Punpanich D, Vanavanan S, Chittamma A, Supaporn T, Effect of enhanced external counterpulsation treatment on renal function in cardiac patients., BMC Nephrol, 2013, 14, 193, doi: 10.1186/1471-2369-14-193.

Additional files

Editorial Notes