Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03348878
Other study ID # 69HCL17_0325
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 16, 2017
Last updated November 16, 2017
Start date November 2017
Est. completion date August 2020

Study information

Verified date November 2017
Source Hospices Civils de Lyon
Contact Patrice NONY, MD
Phone (0)4-72-35-72-31,
Email patrice.nony@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Therapeutic compliance is defined as the degree of coincidence between a person's behavior and prescribing advice given by his or her physician. According to the World Health Organization (WHO), "insufficient adherence is the main reason why patients do not get all the benefits they could expect from their medicines. It causes medical and psychosocial complications, diminishes the quality of life of patients, increases the likelihood of drug resistance, and waste of resources. " In the case of certain conditions such as high blood pressure (hypertension), poor adherence increases the risk of stroke, acute coronary syndrome, and heart failure.

In patients with uncontrolled hypertension under treatment, the issue of therapeutic non-compliance should always be considered before considering the dose (supplemental drug) of antihypertensive therapy.

For each patient participating in the study, medication adherence (for one of the antihypertensive treatments) will be assessed for 2 months using an electronic pill. The antihypertensive treatments considered for the study belong to the following classes: diuretics, beta-blockers, calcium-blockers, ACE (angiotensin-converting enzyme) inhibitors, sartans.

Main objective: care objective: to provide physicians and patients with assistance in case of ineffectiveness or therapeutic escape in a chronic disease such as hypertension, by assessing the compliance profile of each patient.

Secondary objectives: to carry out a quantitative typology of drug adherence in patients with unbalanced HTA under treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient treated with diuretics and / or beta-blockers and / or calcium-blockers and / or ACE inhibitors and / or sartans

- Holter blood pressure total average of 24h greater than 135/85 mmHg or a daytime average greater than 140/90 mmHg or a nighttime average greater than 125/75 mmHg.

- informed consent given

Exclusion Criteria:

- Adults with severe hypertension (BP = 180/110 mmHg) with or without organ failure requiring therapeutic adaptation

- Adults unable to comply with study procedures

- Patients who do not wish to receive generic drugs.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
assessment of drug compliance
assessment of drug compliance using electronic monitoring devices (2 months duration)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Outcome

Type Measure Description Time frame Safety issue
Primary individual pattern of drug compliance compliance measurement using electronic monitoring devices 2 months of follow-up
Secondary Percentage of Prescribed Dosing Days with Correct Intake The percentage of days with accurate dose intake is defined according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203. 2 months of follow-up
Secondary Percentage of Prescribed Dose Taken This measure, though often close to the previous one, focuses on the dose actually received and is defined according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203. 2 months of follow-up
Secondary Percentage of Drug Holidays We define a "drug holiday" as a period of one or more days without drug intake (that is, without MEMS (Medication Event Monitoring System) opening). The statistic counts the number of gaps among the prescribed days, ignoring the length of each individual gap, according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203. 2 months of follow-up
Secondary Time Variability in Drug Intake summary measures consider only the number of medication events each day, according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203. 2 months of follow-up
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03221114 - Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease N/A
Terminated NCT01966952 - Evaluation of Safety Mechanisms of Renal Radioablation(RSRA)for Uncontrolled Hypertension N/A
Withdrawn NCT01939392 - Rapid Renal Sympathetic Denervation for Resistant Hypertension II Phase 2/Phase 3
Completed NCT01699529 - Multi-electrode Radiofrequency Renal Denervation System Feasibility Study N/A
Completed NCT01418261 - SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension N/A
Active, not recruiting NCT01635998 - Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation N/A
Enrolling by invitation NCT02674464 - Reducing Inequities in Care of Hypertension, Lifestyle Improvement for Everyone (RICH LIFE Project) N/A
Completed NCT01996033 - EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension
Terminated NCT01628198 - Impact of Renal SympAthetic DenerVation on Chronic HypErtension N/A
Completed NCT02006758 - Observational Study of the EnligHTN Renal Denervation System in Europe N/A
Not yet recruiting NCT03577990 - Technology Coaching Intervention for Black Women With Hypertension N/A
Completed NCT02418091 - Integrated Population Program for Diabetic Kidney Disease N/A
Completed NCT00888433 - Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2) N/A
Completed NCT01644604 - Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension N/A
Recruiting NCT03209154 - An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment N/A
Recruiting NCT03281772 - Uncontrolled Hypertension Management (TEAM-HTN)
Completed NCT02334033 - Cystatin C and Uncontrolled Hypertension N/A
Recruiting NCT02164435 - Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation N/A
Suspended NCT01679132 - BAROSTIM NEO HTN Pivotal Trial N/A
Completed NCT01628172 - Renal Sympathetic Denervation for the Management of Chronic Hypertension N/A