Antihypertensive Effect of Rostafuroxin Compared With Losartan in Hypertensive Patients Bearing Specified Gene Mutations
Recruitment status was Not yet recruiting
The principal aim of the study is to demonstrate that Rostafuroxin is able to induce a more pronounced reduction of arterial blood pressure respect to Losartan, in hypertensive patients carrying at least one of the pre-specified gene mutations. In previous studies has been demonstrated that these mutations are able to induce specific alterations inducing an increase of sodium (Na) reabsorption at renal tubular level and an increase of arterial blood pressure. Pilot studies have demonstrated that Rostafuroxin is able to reduce the impact of these alterations, and so directly reverse the increase in blood pressure.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Antihypertensive Effect of Different Doses of Rostafuroxin in Comparison With Losartan, Assessed by Office and Ambulatory Blood Pressure Monitoring in a Hypertensive Population Selected According to a Specific Genetic Profile|
- Systolic Blood Pressure [ Time Frame: Week 9 of treatment versus baseline ] [ Designated as safety issue: No ]
Automated sitting and standing SBP and DBP will be recorded by physician at baseline (two visits) and at week 2, 5 and 9 of treatement.
sitting: after the patient has rested for at least 10 minutes in a quiet room. There are five consecutive sitting BP readings with a 30 to 60 seconds interval between the readings; the mean of the last three sitting BP will be used.
The standing BP is measured twice immediately after the patient assumed the standing position.
- Diastolic blood pressure [ Time Frame: Baseline (two visits) and then at week 2, 5 and 9 of treatment ] [ Designated as safety issue: No ]Diastolic blood pressure measurements will be performed at the same times of the systolic blood pressure measurements, as described above.
- Trough-to-peak ratio on Systolic Blood Pressure [ Time Frame: Throughout 24 hours ABPM ] [ Designated as safety issue: No ]Ambulatory Blood Pressure Monitoring (ABPM)will be performed throuhgout 24 hours at baseline and at week 9 of treatement. Readings will be Centralized. The Core Laboratory will be in charge for data interpretation.
- Number of participants with adverse events [ Time Frame: throughout all the study period and follow-up (30 days) ] [ Designated as safety issue: No ]All the Adverse Events will be recorded and followed-up till their resolution. Number of Adverse Events in each group treatment will be computed, including single event frequencies and number of patients with adverse events. AEs will be collected on spontaneous reporting by patients and a number of standard safety procedure: i.e. recording of ECGs, standard blood chemistry and haematology, performed before, during and at the end of the treatment period.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Rostafuroxin 6 micrograms capsules
1 capsule of ROSTAFUROXIN (6 micrograms) once a day before breakfast.
6 microgram capsules
Other Name: PST2238
Experimental: Rostafuroxin 50 micrograms capsules
1 capsule of ROSTAFUROXIN (50 micrograms) once a day before breakfast.
50 micrograms capsules
Other Name: PST2238
Experimental: Rostafuroxin 500 micrograms
1 capsule of ROSTAFUROXIN (500 micrograms) once a day before breakfast.
500 micrograms capsules
Other Name: PST2238
Experimental: Losartan 50 mg encapsulated
1 capsule containing one cpr of Losartan 50 mg once a day before breakfast.
Losartan 50 mg once a day
Other Name: Losaprex
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320397
|Contact: Giovanni Valentini, MD||+39 06 firstname.lastname@example.org|
|Contact: Vittorio Dainese, Biologist||+39 06 email@example.com|
|Ballinasloe, Galway, Ireland|
|James Connolly memorial Hospital|
|Dublin, Ireland, 15|
|Clinical research centre, Beaumont Hospital|
|Dublin, Ireland, 9|
|Unità Operativa di Nefrologia e Dialisi, Ospedale "S. Maria della Scaletta"|
|Imola, Bologna, Italy, 40026|
|Ospedale "Santa Maria"|
|Borgo Val di Taro, Parma, Italy, 43023|
|Divisione di Cardiologia e UTIC Ospedale "Marianna Giannuzzi"|
|Manduria, Taranto, Italy, 74024|
|Reparto di Emodialisi, Ospedale dell'Angelo|
|Mestre, Venezia, Italy, 30174|
|U.O. di Nefrologia e Dialisi, Ospedale San Donato|
|Arezzo, Italy, 52100|
|U.O Nefrologia, Dialisi e Ipertensione, Policlinico S. Orsola-Malpighi|
|Bologna, Italy, 40138|
|Cattedra di Medicina Interna, U.O. Malattie Cardiovascolari, Policlinico Universitario Campus Germaneto|
|Catanzaro, Italy, 88100|
|Centro per l'Ipertensione, Ospedale F. Veneziale|
|Isernia, Italy, 86170|
|U.O.C. di Medicina Interna Universitaria 1, Ospedale San Salvatore|
|L'Aquila, Italy, 67100|
|U.O. Nefrologia e Dialisi, Spedali Riuniti|
|Livorno, Italy, 57100|
|U.O. Nefrologia e Dialisi, Università degli Studi di Milano Azienda Ospedaliera San Paolo|
|Milano, Italy, 20142|
|Divisione di Nefrologia, Dialisi e Ipertensione Ospedale San Raffaele|
|Milano, Italy, 20132|
|Clinica Medica 3, Dipartimento di Scienze Mediche e Chirurgiche|
|Padova, Italy, 35128|
|Reparto Emodialisi, Clinica "Domus Nova"|
|Ravenna, Italy, 48100|
|Nefrologia e Dialisi, Ospedale Infermi|
|Rimini, Italy, 47900|
|Centro per l'Ipertensione, A.S.L. n° 1|
|Sassari, Italy, 07100|
|U.O. Nefrologia e Dialisi Presidio Ospedaliero "Giuseppe Mazzini"|
|Teramo, Italy, 64100|
|Centro Ipertensione Arteriosa, SCU Medicina Interna 4, A.O.U. San Giovanni Battista|
|Torino, Italy, 10126|
|Institute of Cardiology, I Department of Cardiology and Hypertension, Jagiellonian University|
|Krakow, Poland, 31-501|
|Internal Medicine and Gerontology, Jagiellonian University Medical College|
|Krakow, Poland, 31-501|
|Institute of Cardiology, Department of Coronary Disease, Jagiellonian University|
|Krakow, Poland, 31-202|
|Institute of Cardiology, Department of Hypertension, University of Medical Sciences|
|Poznan, Poland, 01-848|
|The Cardinal Stefan Wyszynski Institute of Cardiology - Arterial Hypertension Clinic|
|Warsaw, Poland, 04-628|
|Study Chair:||Jan A Staessen, MD PhD||Laboratory of Hypertension, University of Leuven, B-3000 Leuven - BELGIUM|