Cardiac RehabilitationHARTECNCT03991871
HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study
A study testing External Counter Pulsation (ECP) therapy in people with Cardiac Rehabilitation and Angiogenesis, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
Trial summary
External Counterpulsation Therapy (ECP) is a therapeutic procedure that performed on patients with angina or heart failure to relieve the ischaemic symptoms, improve functional capacity, and quality of life. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Cardiac Rehabilitation, Angiogenesis, Refractory Angina
- What is being tested?
- External Counter Pulsation (ECP) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 21 - 80 years
- Refractory angina CCS III-IV whom are not candidate for Re-revascularization with proven data of: have stenosis on left main more than 50%, stenosis on main coronary right artery more than 70% or stenosis more than 70% on others vessels, conducted in coronary surgery conference with conservative decision (optimal medica mentosa).
Who cannot join
- aorta aneurysm,
- abdominalis aneurysm,
- acute coronary syndrome,
- acute heart failure,
- heavy aortic regurgitation,
- malignant arrhythmia,
Show all 11Show fewer
- blood pressure above 180/100mmHg,
- acute limb ischaemia,
- DVT,
- active thrombophlebitis,
- pregnancy
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Ade Meidian Ambari
Jakarta, DKI Jakarta, 1140
Ade Meidian Ambari, MD,FIHA, 021-5684085 ext. 2209, dr_ade_meidian@yahoo.co.id
About this study
External Counterpulsation Therapy (ECP) is a therapeutic procedure that performed on patients with angina or heart failure to relieve the ischaemic symptoms, improve functional capacity, and quality of life. In recent studies, ECP has already proved to reduce angina symptoms, decrease degree of ischemic in heart train test. External Counterpulsation Therapy (ECP) therapy is a non-invasive technique for sequentially pressuring calf, lower thighs, and upper thighs through developed cuffs at pressure above systolic blood pressure when diastole, then deflated at systole.
Read the detailed description
This study aims to evaluate the effect of ECP therapy on cardiovascular hemodynamic, coronary perfusion, endothelial function, angiogenesis and artery genesis of the coronary blood vessel to refractory angina pectoris patients Refractory angina pectoris patients in Harapan Kita hospitals who do not respond to drugs adequately will be divided by 2 groups, control \& treatment. Inclusion criteria include age 21 - 80 years, Refractory angina CCS III-IV whom are not candidate for Re-revascularization with proven data of: have stenosis on left main more than 50%, stenosis on main coronary right artery more than 70% or stenosis more than 70% on others vessels, conducted in coronary surgery conference with conservative decision (optimal medications).
Exclusion criteria include aorta aneurysm, abdominal aneurysm, acute coronary syndrome, acute heart failure, heavy aortic regurgitation, malignant arrhythmia, blood pressure above 180/100mmHg, acute limb ischemia, DVT, active thrombophlebitis, and pregnancy.
the investigator conducts a double-blind randomized control trial. The participants will get 35 hours ECP treatment, initial treatment pressure is 300 mmHg. whilst control groups will get 75mmHg. At the end of treatment, the investigator compare the hemodynamic effect on coronary perfusion, endothelial function, angiogenesis, and coronary blood vessel arteriogenesis. Quality of Life Improvement based on WHO-5 between groups
- Conditions
- Cardiac Rehabilitation, Angiogenesis, Refractory Angina
- Being tested
- External Counter Pulsation (ECP) therapy
- Keywords
- Refractory Angina, Angiogenesis, External Counterpulsation, Angiopoietin
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Counter Pulsation (ECP) therapyDevice
35 hours ECP treatment in 35 sessions
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 35 hours ECP treatment, initial treatment pressure is 75 mmHg Receives: Device: External Counter Pulsation (ECP) therapy |
| Intervention Group | Experimental | 35 hours ECP treatment, initial treatment pressure is 300 mmHg Receives: Device: External Counter Pulsation (ECP) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiopoietin I concentration
hemodynamic effect on coronary perfusion. angiopoietin I involve in angiogenesis process. this study aims to investigate effects of External counterpulsation for refractory angina patients. it hypothesized to increase collateral artery which mechanism is by increasing angiogenesis process, measured with increase of Angiopoietin I and decrease of Angiopoietin II. Angiopoietin I level will be measured using ELISA technique.
Measured: 7 weeks
MiRNA 92a concentration
microRNAs (miRNAs) are short (20-24 nt) non-coding RNAs that are involved in post-transcriptional regulation of gene expression in multicellular organisms by affecting both the stability and translation of mRNAs. miRNAs are transcribed by RNA polymerase II as part of capped and polyadenylated primary transcripts (pri-miRNAs) that can be either protein-coding or non-coding. The primary transcript is cleaved by the Drosha ribonuclease III enzyme to produce an approximately 70-nt stem-loop precursor miRNA (pre-miRNA), which is further cleaved by the cytoplasmic Dicer ribonuclease to generate the mature miRNA and antisense miRNA star (miRNA*) products. The mature miRNA is incorporated into a RNA-induced silencing complex (RISC), which recognizes target mRNAs through imperfect base pairing with the miRNA and most commonly results in translational inhibition or destabilization of the target mRNA. inhibition of MiRNA 92a prevents endothelial dysfunction.
Measured: 7 weeks
Angiopoietin II concentration
Angiopoietin II established to play a role in blood vessel angiogenesis, antagonist of signaling through Tie2 tyrosine kinase receptor
Measured: 7 weeks
Secondary outcomes (7)
VEGFR-2 concentration
Vascular endothelial growth factor receptor-2 concentration, measured using ELISA
Measured: 7 weeks
VEGF concentration
Vascular endothelial growth factor concentration, measured in plasma, using ELISA method
Measured: 7 weeks
NT pro BNP concentration
Marker of heart failure. NTpro BNP will be measured pre and post external counterpulsation. BNP is actually produced primarily by the left ventricle of the heart (the heart's main pumping chamber). It is associated with blood volume and pressure and with the work that the heart must do in pumping blood throughout the body. Small amounts of a precursor protein, pro-BNP, are continuously produced by the heart. Pro-BNP is then cleaved by the enzyme called corin to release the active hormone BNP and an inactive fragment, NT-proBNP, into the blood.When the left ventricle of the heart is stretched, the concentrations of BNP and NT-proBNP produced can increase markedly. This situation indicates that the heart is working harder and having more trouble meeting the body's demands. This may occur with heart failure as well as with other diseases that affect the heart and circulatory system.
Measured: 7 weeks
6 minute walking test distance (meters)
6 minutes walking test has long been known to measure functional capacity, will be measured pre and post ECP. 6-minutes walking test measuremet is in meter. it measure how far the participants could walk in 6 minutes.
Measured: 7 weeks
NYHA Class index
New York Heart Association (NYHA) Functional Classification to classify severity of heart failure symptoms. It places patients in one of four categories based on how much they are limited during physical activity.
Measured: 7 weeks
CCS Class index
Canadian Cardiovascular Society (CCS) classify angina symptoms into CCS class. it is to classify severity of angina symptoms. it places patients in one of four categories based on the severity of the angina on affecting and limiting phisical activity.
Measured: 7 weeks
WHO 5 index
measuring quality of life, it will be measured pre and post ECP. The 5-item World Health Organization Well-Being Index (WHO-5) is among the most widely used questionnaires assessing subjective psychological well-being. Since its first publication in 1998, the WHO-5 has been translated into more than 30 languages and has been used in research studies all over the world. We now provide a systematic review of the literature on the WHO-5.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Jul 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between two groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bambang Dwiputra, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Investigators
- Ade Meidian Ambari, MD,FIHA, Principal investigator, National Cardiovascular Center Harapan Kita Hospital Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991871
- Sponsor's protocol ID
- HARTEC Study
- Acronym
- HARTEC
- Status last verified
- Jun 2020
- First submitted
- 25 Jun 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim MC, Kini A, Sharma SK. Refractory angina pectoris: mechanism and therapeutic options. J Am Coll Cardiol. 2002 Mar 20;39(6):923-34. doi: 10.1016/s0735-1097(02)01716-3.
PubMed 11897431Loh PH, Cleland JG, Louis AA, Kennard ED, Cook JF, Caplin JL, Barsness GW, Lawson WE, Soran OZ, Michaels AD. Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol. 2008 Apr;31(4):159-64. doi: 10.1002/clc.20117.
PubMed 18404725Henry TD, Satran D, Jolicoeur EM. Treatment of refractory angina in patients not suitable for revascularization. Nat Rev Cardiol. 2014 Feb;11(2):78-95. doi: 10.1038/nrcardio.2013.200. Epub 2013 Dec 24.
PubMed 24366073Ambari AM, Lilihata G, Zuhri E, Ekawati E, Wijaya SA, Dwiputra B, Sukmawan R, Radi B, Haryana SM, Adiarto S, Hanafy DA, Zamroni D, Elen E, Mangkuanom AS, Santoso A. External Counterpulsation Improves Angiogenesis by Preserving Vascular Endothelial Growth Factor-A and Vascular Endothelial Growth Factor Receptor-2 but Not Regulating MicroRNA-92a Expression in Patients With Refractory Angina. Front Cardiovasc Med. 2021 Oct 25;8:761112. doi: 10.3389/fcvm.2021.761112. eCollection 2021.
PubMed 34760951
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study
- ClinicalTrials.gov ID
- NCT03991871
- Acronym / sponsor ID
- HARTEC / HARTEC Study
- Conditions
- Cardiac Rehabilitation, Angiogenesis, Refractory Angina
- Keywords
- Refractory Angina, Angiogenesis, External Counterpulsation, Angiopoietin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
External Counterpulsation Therapy (ECP) is a therapeutic procedure that performed on patients with angina or heart failure to relieve the ischaemic symptoms, improve functional capacity, and quality of life. In recent studies, ECP has already proved to reduce angina symptoms, decrease degree of ischemic in heart train test. External Counterpulsation Therapy (ECP) therapy is a non-invasive technique for sequentially pressuring calf, lower thighs, and upper thighs through developed cuffs at pressure above systolic blood pressure when diastole, then deflated at systole.
Detailed description
This study aims to evaluate the effect of ECP therapy on cardiovascular hemodynamic, coronary perfusion, endothelial function, angiogenesis and artery genesis of the coronary blood vessel to refractory angina pectoris patients Refractory angina pectoris patients in Harapan Kita hospitals who do not respond to drugs adequately will be divided by 2 groups, control \& treatment. Inclusion criteria include age 21 - 80 years, Refractory angina CCS III-IV whom are not candidate for Re-revascularization with proven data of: have stenosis on left main more than 50%, stenosis on main coronary right artery more than 70% or stenosis more than 70% on others vessels, conducted in coronary surgery conference with conservative decision (optimal medications).
Exclusion criteria include aorta aneurysm, abdominal aneurysm, acute coronary syndrome, acute heart failure, heavy aortic regurgitation, malignant arrhythmia, blood pressure above 180/100mmHg, acute limb ischemia, DVT, active thrombophlebitis, and pregnancy.
the investigator conducts a double-blind randomized control trial. The participants will get 35 hours ECP treatment, initial treatment pressure is 300 mmHg. whilst control groups will get 75mmHg. At the end of treatment, the investigator compare the hemodynamic effect on coronary perfusion, endothelial function, angiogenesis, and coronary blood vessel arteriogenesis. Quality of Life Improvement based on WHO-5 between groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison between two groups
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Device: External Counter Pulsation (ECP) therapy35 hours ECP treatment, initial treatment pressure is 75 mmHg |
| Intervention Group | Experimental | Device: External Counter Pulsation (ECP) therapy35 hours ECP treatment, initial treatment pressure is 300 mmHg |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 21 - 80 years
- Refractory angina CCS III-IV whom are not candidate for Re-revascularization with proven data of: have stenosis on left main more than 50%, stenosis on main coronary right artery more than 70% or stenosis more than 70% on others vessels, conducted in coronary surgery conference with conservative decision (optimal medica mentosa).
Key exclusion criteria (11 listed)
- aorta aneurysm,
- abdominalis aneurysm,
- acute coronary syndrome,
- acute heart failure,
- heavy aortic regurgitation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Counter Pulsation (ECP) therapy35 hours ECP treatment in 35 sessions | Device | Control Group, Intervention Group |
Primary outcome
Angiopoietin I concentration
Time frame: 7 weeks
hemodynamic effect on coronary perfusion. angiopoietin I involve in angiogenesis process. this study aims to investigate effects of External counterpulsation for refractory angina patients. it hypothesized to increase collateral artery which mechanism is by increasing angiogenesis process, measured with increase of Angiopoietin I and decrease of Angiopoietin II. Angiopoietin I level will be measured using ELISA technique.
MiRNA 92a concentration
Time frame: 7 weeks
microRNAs (miRNAs) are short (20-24 nt) non-coding RNAs that are involved in post-transcriptional regulation of gene expression in multicellular organisms by affecting both the stability and translation of mRNAs. miRNAs are transcribed by RNA polymerase II as part of capped and polyadenylated primary transcripts (pri-miRNAs) that can be either protein-coding or non-coding. The primary transcript is cleaved by the Drosha ribonuclease III enzyme to produce an approximately 70-nt stem-loop precursor miRNA (pre-miRNA), which is further cleaved by the cytoplasmic Dicer ribonuclease to generate the mature miRNA and antisense miRNA star (miRNA*) products. The mature miRNA is incorporated into a RNA-induced silencing complex (RISC), which recognizes target mRNAs through imperfect base pairing with the miRNA and most commonly results in translational inhibition or destabilization of the target mRNA. inhibition of MiRNA 92a prevents endothelial dysfunction.
Angiopoietin II concentration
Time frame: 7 weeks
Angiopoietin II established to play a role in blood vessel angiogenesis, antagonist of signaling through Tie2 tyrosine kinase receptor
7 secondary outcomes
VEGFR-2 concentration
Time frame: 7 weeks
VEGF concentration
Time frame: 7 weeks
NT pro BNP concentration
Time frame: 7 weeks
6 minute walking test distance (meters)
Time frame: 7 weeks
NYHA Class index
Time frame: 7 weeks
CCS Class index
Time frame: 7 weeks
WHO 5 index
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Results publication: PubMed 11897431Kim MC, Kini A, Sharma SK. Refractory angina pectoris: mechanism and therapeutic options. J Am Coll Cardiol. 2002 Mar 20;39(6):923-34. doi: 10.1016/s0735-1097(02)01716-3.
- Results publication: PubMed 18404725Loh PH, Cleland JG, Louis AA, Kennard ED, Cook JF, Caplin JL, Barsness GW, Lawson WE, Soran OZ, Michaels AD. Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol. 2008 Apr;31(4):159-64. doi: 10.1002/clc.20117.
- Results publication: PubMed 24366073Henry TD, Satran D, Jolicoeur EM. Treatment of refractory angina in patients not suitable for revascularization. Nat Rev Cardiol. 2014 Feb;11(2):78-95. doi: 10.1038/nrcardio.2013.200. Epub 2013 Dec 24.
- Derived from this study: PubMed 34760951Ambari AM, Lilihata G, Zuhri E, Ekawati E, Wijaya SA, Dwiputra B, Sukmawan R, Radi B, Haryana SM, Adiarto S, Hanafy DA, Zamroni D, Elen E, Mangkuanom AS, Santoso A. External Counterpulsation Improves Angiogenesis by Preserving Vascular Endothelial Growth Factor-A and Vascular Endothelial Growth Factor Receptor-2 but Not Regulating MicroRNA-92a Expression in Patients With Refractory Angina. Front Cardiovasc Med. 2021 Oct 25;8:761112. doi: 10.3389/fcvm.2021.761112. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ade Meidian Ambari, MD,FIHA principal investigator
National Cardiovascular Center Harapan Kita Hospital Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Counter Pulsation (ECP) therapy in people with Cardiac Rehabilitation and Angiogenesis, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ade Meidian Ambari, MD,FIHA (628119644123, dr_ade_meidian@yahoo.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiopoietin I concentration (time frame: 7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03991871, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.